Clinical Study Agreement Template for Singapore

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement for a Phase II trial of a new cancer drug to be conducted at Singapore General Hospital, starting March 2025, with specific provisions for biological sample collection and multiple study sites across Singapore."

Document background

Clinical Study Agreements are essential documents used when conducting clinical trials or research studies in Singapore. These agreements establish the legal framework for collaboration between sponsors, research institutions, and investigators while ensuring compliance with Singapore's regulatory requirements. The Clinical Study Agreement defines key aspects including protocol adherence, patient safety measures, data handling, financial terms, and intellectual property rights. It must align with Singapore's strict regulatory framework, including the Medicines Act, Health Products Act, and Human Biomedical Research Act, while meeting international research standards.

Suggested Sections

1. Parties: Identifies all parties to the agreement including Sponsor, Institution, Principal Investigator

2. Background: Outlines the context of the clinical study and the parties' intentions

3. Definitions: Defines key terms used throughout the agreement including Study Protocol, Confidential Information, Study Data, etc.

4. Study Protocol: Details of the approved clinical study protocol and compliance requirements including regulatory frameworks

5. Responsibilities: Detailed obligations of each party in conducting the study in accordance with Singapore regulations

6. Financial Arrangements: Payment terms, schedule, and financial obligations between parties

7. Confidentiality: Provisions regarding confidential information handling in compliance with PDPA

8. Intellectual Property: Rights and ownership of study data, results, and innovations under Singapore IP laws

9. Publication Rights: Terms for publishing study results and data with appropriate reviews

10. Term and Termination: Duration and conditions for ending the agreement

Optional Sections

1. Equipment Provision: Terms for supplied equipment and maintenance requirements

2. Biological Samples: Handling and ownership of biological materials under HBRA requirements

3. Sub-contractor Terms: Terms for third-party service providers and their obligations

4. Multi-center Provisions: Specific terms for studies conducted across multiple sites

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed protocol approved by HSA and relevant authorities

2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms and payment milestones

3. Schedule 3 - Insurance Certificates: Proof of required insurance coverage for clinical trials

4. Schedule 4 - Data Protection Protocol: Specific procedures for handling personal data under PDPA

5. Schedule 5 - Study Timeline: Detailed schedule of study milestones and deadlines

6. Schedule 6 - Reporting Requirements: Templates and schedules for required reports to authorities

7. Schedule 7 - Equipment List: Inventory of provided equipment and terms of use

8. Schedule 8 - Site Requirements: Specific requirements for study site facilities and compliance

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Pharmaceutical
Biotechnology
Medical Devices
Healthcare
Research Organizations

Relevant Teams

Legal
Clinical Operations
Regulatory Affairs
Research & Development
Finance
Quality Assurance

Relevant Roles

Clinical Research Director
Principal Investigator
Legal Counsel
Research Administrator
Medical Director
Regulatory Affairs Manager

Industries

Medicines Act (Chapter 176): Primary healthcare legislation governing the manufacture, import, supply, presentation and sale of medicines and medical devices in Singapore

Health Products Act: Legislation controlling health products, including their manufacture, import, supply, presentation and advertisement

Human Biomedical Research Act (HBRA): Regulates the conduct of human biomedical research, protecting the rights, safety, and well-being of research subjects

Private Hospitals and Medical Clinics Act: Regulates private healthcare institutions and ensures maintenance of proper standards of medical care

Medicines (Clinical Trials) Regulations: Specific regulations governing the conduct of clinical trials involving medicines in Singapore

Health Products (Clinical Trials) Regulations: Detailed requirements for conducting clinical trials of health products

Human Biomedical Research Regulations: Specific regulations under HBRA detailing requirements for human biomedical research

Personal Data Protection Act (PDPA): Framework for data protection and privacy, governing collection, use, disclosure and care of personal data

Singapore Code of Good Clinical Practice (SCGCP): Local standards for designing, conducting, recording and reporting clinical trials in Singapore

Patents Act: Legislation protecting intellectual property rights related to inventions and innovations

Trade Secrets Act: Protection of confidential business information and trade secrets

ICH-GCP Guidelines: International ethical and scientific quality standards for clinical trials

Declaration of Helsinki: International ethical principles for medical research involving human subjects

HSA Guidelines: Health Sciences Authority's regulatory guidelines for clinical trials and research

IRB Requirements: Institutional Review Board requirements for approval and monitoring of clinical research

MOH Directives: Ministry of Health's policies and directives regarding healthcare research and clinical trials

ASEAN Clinical Trial Guidelines: Regional guidelines for conducting clinical trials in ASEAN member states

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Authors

Alex Denne

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